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CompletedNCT04685993Updated Jul 17, 2024Results posted

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial

A Phase 2 interventional study of LPCN 1144 in NASH - Nonalcoholic Steatohepatitis, sponsored by Lipocine Inc.. Completed at 10 sites in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Lipocine Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.

Read the detailed description

This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.

02

Conditions studied

  • NASH - Nonalcoholic Steatohepatitis
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144
  2. Subject must sign the Informed Consent Form to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study
  2. Subjects who are currently receiving any androgens or estrogens
  3. Subjects who are not willing to use adequate contraception for the duration of the study
  4. Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment
  5. Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Treatment A

    LPCN 1144

    Drug: LPCN 1144

Interventions

  • DrugLPCN 1144

    Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).

    Also known as: testosterone undecanoate

05

What researchers measure

Primary outcomes

  1. Safety and Tolerability of LPCN 1144

    Number of subjects presenting with a treatment-emergent adverse events

    Time frame: Baseline to Week 36

06

Results

Posted Jul 17, 2024

Participant flow

Participant flow — Overall Study
MilestoneTreatment A
Started25
Completed23
Not completed2

Outcome measures

PrimarySafety and Tolerability of LPCN 1144

Number of subjects presenting with a treatment-emergent adverse events

Time frame:
Baseline to Week 36
Reported as:
Count of participants · Participants
Safety and Tolerability of LPCN 1144
ParticipantsTreatment A
Safety and Tolerability of LPCN 114410

Adverse events

Collected over 9 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment A1/25 (4%)1/25 (4%)2/25 (8%)
Most frequent serious events
Most frequent serious events
EventTreatment A
Respiratory FailureRespiratory, thoracic and mediastinal disorders1/25
Most frequent other events
Most frequent other events
EventTreatment A
Upper respiratory infectionInfections and infestations2/25

Baseline characteristics

Subjects who completed the 38 week study LPCN 1144-18-002 as planned and wanted to continue in this open label extension study

Age, Continuous
Age, Continuous(years)Treatment A
Mean53.8 ± 8.4
Sex: Female, Male
Sex: Female, Male(Participants)Treatment A
Female0
Male25
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment A
Hispanic or Latino9
Not Hispanic or Latino16
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment A
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White24
More than one race0
Unknown or Not Reported0
07

Study locations

10 sites
  • Clinical Trials Research
    Roseville, California 95661, United States
  • Sensible Healthcare, LLC
    Ocoee, Florida 34761, United States
  • Jubilee Clinical Research, Inc.
    Las Vegas, Nevada 89106, United States
  • R&H Clinical Research
    Katy, Texas 77494, United States
  • Sun Research Institute
    San Antonio, Texas 78215, United States
  • Endeavor Clinical Trials
    San Antonio, Texas 78229, United States
  • Pioneer Research Soultions
    Sugar Land, Texas 77479, United States
  • Advanced Clinical Research - Gut Whisperer
    Riverton, Utah 84065, United States
  • Granger Medical Clinic
    West Valley City, Utah 84120, United States
  • Manassas Clinical Research Center
    Manassas, Virginia 20110, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 1, 2021

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT04685993
Lead sponsor
Lipocine Inc.
Responsible party
Sponsor
First posted
Dec 28, 2020
Start date
Nov 11, 2020
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022
Results posted
Jul 17, 2024
Last update
Jul 17, 2024

Study contacts

Anthony DelConte
study director · Lipocine Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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